One patient experienced a grade 1 allergic reaction and the other grade 3 hives. The jevtana injection is a clear yellow to brownishyellow viscous solution, if appropriately stored. Cabazitaxel is used together with prednisone to treat prostate cancer that has spread to other parts of the body metastatic. Cabazitaxel with prednisone is commonly given with the goal of improving survival in men with prostate cancer, but usually not with the goal of cure. The prostate is a gland that is sized and shaped like a walnut, which is found in a mans reproductive system and located below the bladder, near the rectum and around the urethra. It is an antineoplastic agent that belongs to the taxane class. Jevtana cabazitaxel 215000030020 antimicrotubular criteria for coveragenoncoverage jevtana cabazitaxel will be considered for coverage under the pharmacy benefit program when the following criteria are met. Contraindicated for use in pregnant women because drug can cause fetal harm and potential loss of pregnancy. Jevtana summary of product characteristics smpc emc. Nccn clinical practice guidelines in oncology prostate cancer version 2.
Jevtana cabazitaxel injection is an antineoplastic agent belonging to the taxane class that is for intravenous use. Jevtana will be given by a drip infusion into one of your veins intravenous use in. Mar 24, 2020 jevtana cabazitaxel is a cancer antineoplastic medication used together with prednisone to treat prostate cancer that has spread to other parts of the body metastatic. Cabazitaxel is the main circulating compound in human plasma. Click the image and it will be inserted into the slide. Jevtana will be given by a drip infusion into one of your veins intravenous use in hospital for about an hour. Fda for the treatment of hormonerefractory prostate cancer on june 17, 2010.
Cabazitaxel is minimally excreted via the kidney 2. Fda label information for this drug is available at dailymed. Phase iii trial of cabazitaxel plus abiraterone in patients with. It is prepared by semisynthesis with a precursor extracted from yew needles. Based on the results of the tropic trial, cabazitaxel 25 mgm 2 has been fdaapproved since 2010 specifically for metastatic crpc patients who have already received prior docetaxel chemotherapy. Cabazitaxel to treat prostate cancer chemotherapy news. Download figure open in new tab download powerpoint. Aug, 2015 mean cabazitaxel halflife will be plotted over time for cabazitaxel day 1, cycle 1 and cabazitaxel coadministered with enzalutamide day1, cycle 2.
Patients receiving concomitant capecitabine and oral coumarin. Jevtana is contraindicated in patients with neutrophil counts of. Cabazitaxel for hormonerelapsed metastatic prostate cancer. In these studies, cabazitaxel was given at a dosage of 25 mgm. It was developed by sanofiaventis and was approved by the u. Final appraisal determination cabazitaxel for hormone relapsed metastatic prostate cancer treated with docetaxel issue date. It was described as clearly a major advance in secondary chemotherapy for advanced. Cabazitaxel is used together with prednisone to treat prostate cancer that has spread to other parts of the body metastatic cabazitaxel is usually given after other cancer medicines have been tried without success. Missing information makes it difficult to approve requests and creates a longer processing time. Cancer cells that express pgp become resistant to taxanes, and the effectiveness.
Crossover to cabazitaxel was not allowed for the mitoxantrone group. The quality of the pdf file is reduced with this method, but you can open the full pdf file by doubleclicking the image when viewing or editing in normal view. The patient has castrationresistant metastatic prostate cancer and. Jevtana cabazitaxel injection, for intravenous use. Learn about jevtana, a nccn designated category 1 secondline therapy for patients with metastatic castrationresistant prostate cancer mcrpc previously treated with a docetaxelcontaining regimen. The prostate is a gland that is sized and shaped like a walnut, which is found in a mans reproductive system and located below the bladder.
Cancer care ontario is committed to ensuring accessible services and communications to individuals with disabilities. Jevtana cabazitaxel injection for advanced prostate cancer. Jevtana cabazitaxel dosing, indications, interactions. Jevtana must be prepared diluted before it is given. Cabazitaxel is used together with prednisone to treat prostate cancer that has spread to. The recommended dose of jevtana is based on calculation of the body surface area bsa, and is administered as a onehour intravenous infusion every. The pdf file should be the first option within the insert dialog window. Patients had their luteinising hormonereleasing hormone lhrh agonist therapy continued. Jevtana is usually given after other cancer medicines have been tried without success. Side effects of jevtana cabazitaxel injection, warnings. No formal pharmacokinetic studies were conducted with cabazitaxel in patients with renal. Side effects of jevtana cabazitaxel injection, warnings, uses.
Jevtana cabazitaxel is a chemotherapy drug used to treat prostate cancer, a disease that occurs when cells in the prostate start to grow out of control. To receive any information on this website in an alternate format, please contact communications by phone at. Unfortunately, use of the drug was limited for many patients due to. Jevtana cabazitaxel injection, for intravenous use initial u. Cabazitaxel in metastatic castrationresistant prostate cancer. You will need to take prednisone every day during your treatment with cabazitaxel injection. Treatment with cabazitaxel was prognostic for survival. Impact of cabazitaxel on 2year survival and palliation of tumour. Preparation and administration for jevtana cabazitaxel. Seven metabolites were detected in plasma including 3 active metabolites issued form odemethylations, with the main one accounting for 5% of parent exposure. In the insert object box, select create from file, and then enter the pdf file location. Cabazitaxel side effects, dosage, interactions drugs. It is a microtubule inhibitor, and the fourth taxane to be approved as a cancer therapy. It is important that you take prednisone exactly as prescribed by your doctor.
Cabazitaxel versus docetaxel both with prednisone in. Cabazitaxel binds mainly to human serum albumin 82% and lipoproteins. Xelodawarfarin interaction xeloda warfarin interaction. Sequencing of cabazitaxel and abiraterone acetate after. Cabazitaxel for hormonerelapsed metastatic prostate. Cabazitaxel was used according to the summary of product characteristics. Cabazitaxel is approved to be used with prednisone to treat prostate cancer that has metastasized spread to other parts of the body in men whose cancer is castration resistant has not responded to treatments that lower testosterone levels and who have already been treated with chemotherapy that included docetaxel. See important safety information and full prescribing information, including boxed warning.
Indicate the full name of the medication administered including strength if applicable e. Cabazitaxel, a microtubule inhibitor, is a chemotherapeutic agent for the treatment of advanced prostate cancer. Tell your doctor if you have ever had an unusual or. Cabazitaxel drug monograph pharmacy benefit management. Jevtana is indicated in combination with prednisone for the treatment of patients with. Cabazitaxel is a novel tubulinbinding taxane that differs from docetaxel because of its poor affinity for pglycoprotein pgp, an atpdependent drug efflux pump. Cabazitaxel versus docetaxel both with prednisone in patients. Full text cabazitaxel in the treatment of metastatic castration. Neutropenia and hypersensitivity see full prescribing information for complete boxed warning. Mean cabazitaxel halflife will be plotted over time for cabazitaxel day 1, cycle 1 and cabazitaxel coadministered with enzalutamide day1, cycle 2. Jevtana is a prescription anticancer medicine used with the steroid medicine prednisone. Clinical concepts for cabazitaxel in the management of metastatic. Jan 01, 2020 cabazitaxel is a cancer medicine that interferes with the growth and spread of cancer cells in the body. People receiving cabazitaxel should be aware that the drug can cause infections and other serious problems.
Call your doctor for medical advice about side effects. Jan 22, 2020 jevtana cabazitaxel is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Taxotere docetaxel injection concentrate, intravenous infusion iv prescribing information. Toxicity management was followed as described in the prescribing information document on cabazitaxel. Cabazitaxel is usually given after other cancer medicines have been tried without success. Insert pdf file content into a powerpoint presentation. Each ml of concentrate contains 40 mg cabazitaxel anhydrous, 1. Jevtana is used to treat men with castrationresistant prostate cancer prostate cancer that is resistant to medical or surgical treatments that lower testosterone that has worsened progressed after treatment with other medicines, including docetaxel. Cabazitaxel is the first chemotherapy to have shown a survival benefit in this setting since docetaxel. Treatment was repeated every 21 days for a maximum of 10 cycles. The pharmacokinetics of cabazitaxel showed doseproportional drug exposure. Jevtana cabazitaxel is a cancer medicine that interferes with the growth and spread of cancer cells in the body jevtana is used together with prednisone to treat prostate cancer that has spread to other parts of the body metastatic jevtana is usually given after other cancer medicines have been tried without success. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are.
To demonstrate the superiority of cabazitaxel plus prednisone at 25 mgm2 arm a or 20 mgm2 arm b versus docetaxel plus prednisone arm c in term of overall survival os in participants with metastatic castration resistant prostate cancer mcrpc and not previously treated with chemotherapy. Please be sure to complete this form in its entirety. Open your powerpoint presentation on the page you want to insert the pdf within. Cabazitaxel versus docetaxel both with prednisone in patients with metastatic castration resistant prostate cancer firstana the safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Cabazitaxel is metabolized in the liver primarily by cyp 3a45 isoenzymes and, to a lesser degree, by cyp2c8 enzymes. It is prepared by semisynthesis with a precursor extracted from yew needles the chemical name of cabazitaxel is 2. Practical information for handling and administration of jevtana for doctors, nurses and pharmacists is provided with this leaflet. Firstline chemotherapy for metastatic castrationresistant prostate cancer mcrpc with docetaxel d every 3 weeks plus prednisone yields a median overall survival os of nearly 19 months. Each ml contains 40 mg cabazitaxel anhydrous and 1. For a complete listing, see the dosage forms, composition and packaging section of the product monograph. Set aside the jevtana injection and supplied diluent vials. Firstline all among 58 oncaspartreated patients enrolled in study 1, clinical allergic reactions were reported in 2 patients 3%. Cabazitaxel injection comes as a liquid to be given intravenously into a vein over 1 hour by a doctor or nurse in a medical facility. Cabazitaxel binds to and stabilizes tubulin, resulting in the inhibition of microtubule depolymerization and cell division, cell cycle arrest in the g2m phase, and the inhibition of tumor cell proliferation.
April 2016 nhs trusts purchase cabazitaxel in preprepared intravenousinfusion bags, not in vials, and the company provides cabazitaxel with the discount agreed in the patient access scheme. This emedtv article lists other important precautions and warnings with cabazitaxel and explains why the drug is not suitable for some people. Jevtana is a nccn designated category 1 secondline therapy for mcrpc. Our jevtana cabazitaxel side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Cancer cells that express pgp become resistant to taxanes, and the effectiveness of docetaxel can be limited by its high substrate affinity for pgp. Jevtana is used together with prednisone to treat prostate cancer that has spread to other parts of the body metastatic. Enzalutamide and cabazitaxel in treating patients with. Obtain frequent blood counts to monitor for neutropenia. In firstana, cabazitaxel and docetaxel were compared in a headtohead randomized trial designed to show superiority of cabazitaxel over docetaxel with respect to overall survival. Cabazitaxel is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Cabazitaxel jevtana medical clinical policy bulletins aetna. Cabazitaxel previously xrp6258, trade name jevtana is a semisynthetic derivative of a natural taxoid. Nov 09, 2018 cabazitaxel is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Cabazitaxel is extensively metabolised in the liver 95%, mainly by the cyp3a isoenzyme 80% to 90%.
Cabazitaxel is a semisynthetic derivative of the natural taxoid 10deacetylbaccatin iii with potential antineoplastic activity. Jun 11, 2018 jevtana must be prepared diluted before it is given. Noncompartmental pharmacokinetic analysis will be performed on individual concentrationtime data to calculate halflife from 0 hours to last measurable concentration for cabazitaxel. Food and drug administration fda and european medicines agency approval as a therapy for patients with metastatic hormoneresistant prostate cancer mhrpc previously treated with a docetaxelcontaining regimen package insert, jevtana sanofi. This article also provides some important tips about when and how to receive your infusion. Mar 10, 2011 cabazitaxel is a novel tubulinbinding taxane that differs from docetaxel because of its poor affinity for pglycoprotein pgp, an atpdependent drug efflux pump. Jevtana 60 mg solution for injection, singledose vial.